Intravenous lignocaine infusion for analgesia after laparoscopic fundoplication surgery: A double-blind, randomised, placebo-controlled trial.

Abstract

This study aimed to determine if intravenous lignocaine infusion reduces post-operative pain following laparoscopic fundoplication surgery and to validate the safety of intravenous lignocaine at the dose tested. This was an equally randomised, double-blind, placebo-controlled, parallel-group, single centre trial. Adult patients undergoing laparoscopic fundoplication were recruited. The intervention group received 1 mg/kg intravenous lignocaine bolus then an intravenous infusion at 2 mg/kg/hour for 24 hours. The primary outcome was pain, measured using a numeric rating scale for 30 hours post-operatively. Secondary outcomes were nausea and vomiting, patient controlled analgesia demand, adverse events, serum lignocaine concentration, length of hospital stay and inspiratory capacity. The study was terminated after an interim analysis of 24 patients showed evidence of futility. There was no difference in post-operative pain scores (lignocaine versus control, mean ± SD) at rest (2.0 ± 2.7 vs 2.1 ± 2.4, p=0.286) or with movement (2.0 ± 2.6 vs 2.6 ± 2.7, p=0.487). Respiratory performance was worse in the lignocaine group (P = 0.014). Three adverse events occurred in the lignocaine group (25% of patients). Intravenous lignocaine did not provide clinically significant analgesia to patients undergoing laparoscopic fundoplication. This trial cannot confirm the safety of intravenous lignocaine at the dose tested.